# K080499: Magstim Double 70MM Air Film Coil, Model 3910-00

- Pathway: 510(k) (Traditional)
- Applicant: The Magstim Company, Ltd.
- Decided: Dec 8, 2008 after 287 days
- Product code: GWF (Stimulator, Electrical, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K905059 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060847: Magstim 200-2, Magstim Company Us, LLC (2006) Summary page 2.
- K051864: Magstim RAPID2, Magstim Super RAPID2, Models 3004-000, 3005-00, The Magstim Company, Ltd. (2005) Summary page 2.

## Indications for use
The Magstim® Double 70mm Air Film Coil is a stimulating coil solely intended for use with the Magstim® Rapid 2 Stimulating Unit for the purposes of peripheral nerve stimulation. The coil is an accessory of the Magstim Rapid 2 Unit.

Source page: https://510kreport.com/device/K080499
Methodology: https://510kreport.com/methodology